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Although premium cigars represent just 2.1% percent of all cigars smoked in the United States (according to the FDA, 300 million of the 14 billion total cigars sold), the vibrant creativity that has come to represent this small handmade portion of the cigar market will be hit with the overwhelming burden of complying with rules that require FDA approval for every cigar not on the market before February 15, 2007.

Within each brand, every size of that blend that was introduced after that date will have to apply for FDA approval, or be off the market, by August 2018. So literally thousands of blends would have to apply, something no one (including the FDA) expects to happen.

In its public statements regarding the rule and within the 499-page rule itself, the FDA repeatedly alludes to the need to regulate cigars to protect children. But a closer look shows the facts don’t support the claim. In fact, at least one of the statements the FDA told the public about this is demonstrably false.

FDA Misstates Current Law

In its press announcement of the new rule, the FDA made the following statement: “Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18.”

This claim struck me as odd, at least in respect to cigars, so I asked an FDA spokesman for clarification. Despite multiple emails back and forth, I never got a substantive answer to my question: Does the FDA know of anywhere in the U.S. where the sale of cigars to minors (under 18) was not already illegal?

At one point in the exchange, I was referred to the “CDC [Center for Disease Control] or a group like the Campaign for Tobacco-Free Kids,” which seemed strange given that the FDA had just designated itself the chief regulator of cigars.

Despite that, I asked both groups that the FDA referred me to. The Campaign for Tobacco-Free Kids confirmed that every state prohibits sales to minors (and that Alabama currently also prohibits sales to those age 19). The CDC spokesman made it even more clear that the FDA was wrong in its announcement that prior to these rules federal law did not prohibit sales of cigars to minors.

The CDC spokesman wrote the following back to me: “In response to your question about selling tobacco products to persons under the age of 18. The federal minimum age of sale for tobacco products is 18. States are free to make it higher, but not lower.”

In other words, the federal agency that the FDA referred me to directly contradicted the statement put out by the FDA. Of course, by then the FDA’s misstatement had already been repeated in numerousnews accounts of the new regulation.

FDA Cites 29-Year-Old Adults as Evidence of Youth Usage

But the FDA’s deception on this issue doesn’t end there. Within the rules, especially in the justification for not exempting premium cigars, the FDA repeatedly conflates underage use of cigars with choices made by adults.

The final FDA rule repeatedly uses the phrase “youth and young adult(s),” 56 times to be exact, within the rule. So I asked the FDA how they defined young adults and “what would be the oldest a person could be and still be considered a ‘young adult’ by the FDA?”

I was told “young adults” and other references to age groups depended on the specific studies being cited. A look at those studies show that some used 25 while others used 29 as the upper limit for “young adults.”

So while the FDA is using the age-old justification that their rules are necessary “for the children,” the fact is they are citing studies about the choices made by 29-year-old adults, men and women who could have legally served in the U.S. military for over a decade, to do it.

New Rule Really About Restricting the Choices of Adults

At other times, the FDA drops the pretense of the regulations being about youth access all together. At one point in the rule (page 178), the FDA states that it agrees with the proposition that if premium cigars are exempt from the rule, “the current population of premium cigar users would be left unprotected, potentially decreasing the likelihood that they would quit.”

Further, in the FDA’s announcement, a quote from Health and Human Services Secretary Sylvia Burwell specifically states that the aim of the rule goes far beyond children: “Today’s announcement is an important step in the fight for a tobacco-free generation.” So if anyone had any doubts that the FDA wants to totally eliminate tobacco, that statement by a cabinet-level appointee should erase them.

The irony is, even if the new rules were actually designed just to restrict use by minors, the grandfather date set by the legislation that empowered the FDA to regulate cigars means that, barring a sweeping act from Congress, there will always be pre-2007, non-FDA regulated tobacco products out there for lawbreaking minors to find ways to illegally acquire. Better enforcement of laws already on the books might fix that, but the regulations announced last week won’t.

Meanwhile, thousands of premium handmade cigars will be wiped off the market in just over two years, serving no purpose except to restrict the choices available to the adults who choose to enjoy them.

19 Responses to “News: FDA Misleading Public About Cigars and Youth”

“So while the FDA is using the age-old justification that their rules are necessary “for the children” the fact is they are citing studies about the choices made by 29 year old adults – men and women who legally could have served in the U.S. military for over a decade – to do it.”

This reminds me of my younger days when the draft age was much younger than the legal drinking age. A common slogan back then was, “If I’m old enough to get drafted and shafted, then I’m old enough to get loose on the juice!” That was Viet Nam era.

They don’t explicitly say every cigar size is a different product, but it repeatedly refers ingredient lists along with changes to the quantities of those ingredients as triggering new filings. Since different sizes are just the same ingredients in differing quantities it seems clear that each size is a different product. Further, part of the FDA’s regulations are the marketing, so the fact that each vitola has a different name also suggests each is a unique product that must be evaluated by the FDA.

The FDA is even more explicit in the rule regarding e-cigs, noting that percentage changes of the same ingredients/components in a blend triggers the need for new approvals. The FDA admits this will be a big burden but says they expect manufacturers to deal with this by pairing down the offerings.

Also, when you consider how this would work with pre-2007 products, a new size would need to be a new product. Otherwise, a manufacturer could take a blend from a pre-2007 grandfathered cigar and introduce a new 7 x 70 size and tell the FDA it has no obligation to apply for approval as “Substantially Equivalent” as it is merely a grandfathered product. Going even further, if new sizes are not new products, a cigarette company could introduce Camel double longs onto the market at any time without any FDA approval, and I don’t see anyway you can interpret Tobacco Control Act or the the FDA rules or actions as allowing for that.

Ignoring e-cigarettes, which have a lot of issues for the FDA and e-cig makers, I am not sure yet that’s how the FDA will interpret the rules.

The deeming regs include this:

Question: Many expressed concern that requiring cigars to comply with the PMTA requirements would either force cigars off the market or require them to mimic cigarettes in uniformity of size, shape, and taste, which would change the fundamental nature of the cigar industry…

Answer: FDA disagrees. Sections 905 and 910 of the FD&C Act establish specific requirements that apply to new tobacco products before they may be marketed. Some cigars may
be grandfathered and other products may have valid predicate products and may be able to avail themselves of the SE pathway to market. FDA generally expects that cigars with blending
changes (other than blending changes to address the natural variation of tobacco, FDA’s policy for which is discussed in the response to Comment 28) will be able to successfully use the SE pathway so long as the blending change does not significantly raise levels of HPHCs in the product (i.e., raising different questions of public health).

mike-
PMTA is for new products that cannot show they are “substantially equivalent” (SE) to pre-2007 products, while SE approval process has always been how people expect most if not all cigars to gain approval. (The SE process should be easier – though not easy – to navigate than PMTA but it also has some hurdles PMTA doesn’t. My understanding is under the law PMTA applications are entitled to a response after a certain amount of time, while the FDA can sit on SE applications indefinitely.)

What the FDA seems to me to be saying in the quotes you cite is: don’t worry about PMTA, as most small changes to cigars outside “blending changes to address the natural variation of tobacco” will fall under the SE process. (The “blending changes to address the natural variation of tobacco” comment seems to address the fact that even a pre-2007 cigar’s blend is tweaked from year to year to maintain consistent flavor, and without it every new batch of cigars could be a new product and no cigar would be pre-2007.)

That is hardly comforting to cigar makers who will need to file for an SE approval for every post-2007 product they want to sell past August 2018, and it doesn’t say anything about what is or isn’t a product that will need to go through the SE process.

Precisely…tobacco. It’s a single-ingredient product, so what’s all the fuss about. I buy peanut butter on which the ingredient list simply says ‘Peanuts’. I’m sure there is as much biodiversity in the realm of peanuts as there is in the world of tobacco. I wonder if Skippy and JIF have to document their peanut varietals and what percentages are used in each batch/brand. Ridiculous.

This is absurd and will not accomplish the purpose they state by virtue of the fact that other cigars will still be available. So who is fooling who and why do they really want to restrict new premium cigar manufacturers from entering the marketplace? Do they really expect people to believe this nonsense? How gullible do they think we are? What ever happened to free market, fair trade, competition as opposed to monopoly??

They’re manufactured by somebody. They will have the same rules as any other brand. A shop with an in-house roller will have to register as a manufacturer, although with very low volume, the fees and paperwork should be much less.

One of the most bootlegged products in the country are now cigarettes. Thhis nation was founded on bootlegged,rum, tea and tobacco. The FDA at their best is at worst going to drive sales underground. This government since 2009 has done it’s best to destroy the economy and middle class.

Ron –
Cigarette bootlegging is an entirely different matter due to the vastly larger demand for cigarettes over cigars. While there is occasionally a large-scale theft of cigars from a warehouse, there’s very little of buying cigars in a state with low (or non-existent) cigar tax and selling them in a high-tax state. Also, the FDA regulations, being national, would have no impact on the differences in state taxes. Someone could smuggle cigars from the Dominican or Nicaragua to the U.S. and avoid all the taxes or regulations, but, again, the market is so small it likely wouldn’t be profitable. Consider the numbers: about 300-320 million premium hand rolled cigars are sold annually in the U.S. For cigarettes, it’s about 265 billion (over 14 billion packs).